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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
Products for which the marketing authorisations are
recommended for suspension by the CHMP on 22 January 2015
Some of these medicinal products may be considered critical by the individual EU Member States. The suspension of the concerned marketing authorisation(s) may be deferred by the period for which the medicinal product is considered critical.
Article 31 of Directive 2001/83/EC
Procedure number: EMEA/H/A-31/1408
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 2/131
Austria Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Austria
Esomeprazole magnesium
Esomeprazol Arcana 20 mg magensaftresistente Hartkapseln
20 mg Gastro - resistant capsule, hard
Oral use
Austria Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Austria
Esomeprazole magnesium
Esomeprazol Arcana 40 mg magensaftresistente Hartkapseln
40 mg Gastro - resistant capsule, hard
Oral use
Austria Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Austria
Esomeprazole magnesium
Neximyl 20 mg magensaftresistente Hartkapseln
20 mg Gastro - resistant capsule, hard
Oral use
Austria Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Austria
Esomeprazole magnesium
Neximyl 40 mg magensaftresistente Hartkapseln
40 mg Gastro - resistant capsule, hard
Oral use
Austria Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Austria
Candesartan cilexetil
Candesartan Arcana 4mg Tabletten
4 mg Tablet Oral use
Austria Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Austria
Candesartan cilexetil
Candesartan Arcana 8mg Tabletten
8mg Tablet Oral use
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Austria Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Austria
Candesartan cilexetil
Candesartan Arcana 16mg Tabletten
16 mg Tablet Oral use
Austria Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Austria
Candesartan cilexetil
Candesartan Arcana 32mg Tabletten
32 mg Tablet Oral use
Austria Genericon Pharma GmbH Hafnerstr. 211
8054 Graz Austria
Nebivolol Nebivolol Genericon 5 mg Tabletten
5 mg Tablet Oral use
Austria ratiopharm Arzneimittei- Vertriebs-GmbH
Albert-Schweitzer-Gasse 3 1140 Wien
Austria
Desloratadine Desloratadin ratiopharm 2,5 mg Schmelztabletten
2,5 mg Orodispersible tablet
Oral use
Austria ratiopharm Arzneimittei- Vertriebs-GmbH
Albert-Schweitzer-Gasse 3 1140 Wien
Austria
Desloratadine Desloratadin ratiopharm 5 mg Schmelztabletten
5 mg Orodispersible tablet
Oral use
Belgium Apotex Europe B.V.
Darwinweg 20 NL 2333 CR Leiden Netherlands
Desloratadine Desloratadine Apotex 5 mg Film - coated tablet
Oral use
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Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Donepezil Donepezil Odis Mylan 5 mg Orodispersible tablet
Oral use
Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Donepezil Donepezil Odis Mylan 10 mg Orodispersible tablet
Oral use
Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Repaglinide Repaglinide Mylan 0,5 mg Pharma
0,5 mg Tablet Oral use
Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Repaglinide Repaglinide Mylan 1 mg Pharma
1 mg Tablet Oral use
Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Repaglinide Repaglinide Mylan 2mg Pharma
2 mg Tablet Oral use
Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Candesartan Candesartan Mylan 8 mg Tablet Oral use
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Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Candesartan Candesartan Mylan 16 mg Tablet Oral use
Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Candesartan Candesartan Mylan 32 mg Tablet Oral use
Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Esomeprazole Esomeprazole Mylan 20 mg Gastro - resistant capsule, hard
Oral use
Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Belgium
Esomeprazole Esomeprazole Mylan 40 mg Gastro - resistant capsule, hard
Oral use
Belgium Takeda Belgium Gentsesteenweg 615 1080 Brussels Belgium
Alendronic acid Alendromono 70 mg Tablet Oral use
Belgium Teva Pharma Belgium NV Laarstraat 16
2610 Wilrijk Belgium
Desloratadine Desloratadine Teva 2,5 mg Orodispersible tablet
Oral use
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Belgium Teva Pharma Belgium NV Laarstraat 16
2610 Wilrijk Belgium
Desloratadine Desloratadine Teva 5 mg Orodispersible tablet
Oral use
Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole Ropinirole Accord 0,5 mg Film - coated tablet
Oral use
Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole Ropinirole Accord 1 mg Film - coated tablet
Oral use
Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole Ropinirole Accord 2 mg Film - coated tablet
Oral use
Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole Ropinirole Accord 5 mg Film - coated tablet
Oral use
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Bulgaria Alkaloid - INT d.o.o.
Šlandrova 4
1231 Ljubljana - Črnuče Slovenia
Cefpodoxime FOXERO 200 mg Tablet Oral use
Bulgaria Aquachim AD
blvd. Prof. Tsvetan Lazarov 83
Sofia 1582 Bulgaria
Quetiapine Aquatiapine 25 mg Film - coated
tablet
Oral use
Bulgaria Aquachim AD
blvd. Prof. Tsvetan Lazarov 83
Sofia 1582 Bulgaria
Quetiapine Aquatiapine 100 mg Film - coated
tablet
Oral use
Bulgaria Aquachim AD
blvd. Prof. Tsvetan Lazarov 83
Sofia 1582 Bulgaria
Quetiapine Aquatiapine 200 mg Film - coated
tablet
Oral use
Bulgaria Generics (UK) Ltd
Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Esomeprazole magnesium
Esopragen 20 mg Gastro - resistant
capsule, hard
Oral use
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Bulgaria Generics (UK) Ltd
Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Esomeprazole magnesium
Esopragen 40 mg Gastro - resistant
capsule, hard
Oral use
Bulgaria Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b 14078 Praha 4 Czech Republic
Trimetazidine Apstar 35 mg
prolonged-release tablets
35 mg Prolonged - release tablet
Oral use
Bulgaria Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Trimetazidine Trimetazigen MR 35 mg Prolonged - release tablet
Oral use
Bulgaria Neo Balkanika EOOD 35 Zemliane Str.
Sofia 1618 Bulgaria
Nebivolol Bivolet 5 mg Tablet Oral use
Bulgaria Sandoz Pharmaceuticals d.d.
Verovskova 57 Ljubljana SI-1000 Slovenia
Trimetazidine Energotrim 35 mg Prolonged -
release tablet
Oral use
Bulgaria Tchaikapharma Highquality Medicines
1 G. M. Dimitrov Blvd.
Sofia 1172 Bulgaria
Bosentan Pulmohyperta 62,5 mg Film - coated
tablet
Oral use
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Bulgaria Tchaikapharma Highquality Medicines
1 G. M. Dimitrov Blvd.
Sofia 1172 Bulgaria
Bosentan Pulmohyperta 125 mg Film - coated
tablet
Oral use
Croatia Alkaloid d.o.o.
Ulica grada Vukovara 226 F Zagreb 10000
Croatia
Cefpodoxime Rexocef 200 mg filmom obložene tablete
200 mg Film - coated tablet
Oral use
Croatia Belupo, lijekovi i kozmetika d.d.
Ulica Danica 5 Koprivnica 48000 Croatia
Desloratadine Alerdin 2,5 mg raspadljive tablete za usta
2,5 mg Orodispersible tablet
Oral use
Croatia Belupo, lijekovi i kozmetika d.d.
Ulica Danica 5 Koprivnica 48000 Croatia
Desloratadine Alerdin 5 mg raspadljive tablete za usta
5 mg Orodispersible tablet
Oral use
Croatia Fidifarm d.o.o.
Obrtnička 37, Bestovje Rakitje 10437
Croatia
Desloratadine Sinalerg 5 mg filmom obložene tablete
5 mg Film - coated tablet
Oral use
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Croatia Jadran Galenski Laboratorij d.d.
Svilno 20, Rijeka 51000
Croatia
Desloratadine Escontral direkt 2,5 mg raspadljiva tableta za usta
2,5 mg Orodispersible tablet
Oral use
Croatia Jadran Galenski Laboratorij d.d.
Svilno 20, Rijeka 51000
Croatia
Desloratadine Escontral direkt 5 mg raspadljiva tableta za usta
5 mg Orodispersible tablet
Oral use
Croatia PharmaS d.o.o.
Radnička cesta 47 Zagreb 10000 Croatia
Tramadol/paraceta mol
Tramadol/Paracetamol PharmaS 37,5 mg/
325 mg filmom obložene tablete
37,5 mg/325 mg
Film - coated tablet
Oral use
Croatia PharmaS d.o.o.
Radnička cesta 47 Zagreb 10000 Croatia
Escitalopram Escitalopram PharmaS 10 mg filmom
obložene tablete
10 mg Film - coated tablet
Oral use
Croatia Sandoz d.o.o.
Maksimirska 120 Zagreb 10000 Croatia
Trimetazidine hydrochloride
Vazidin 35 mg tablete s produljenim oslobađanjem
35 mg Prolonged - release tablet
Oral use
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Cyprus Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Alendronic acid Alendronic Acid Accord 70 mg Tablet Oral use
Cyprus Delorbis Pharmaceuticals Ltd 17 Athinon Street
Ergates Industrial Area 2643 Ergates
P.O. Box 28629 2081 Lefkosia Cyprus
Entacapone Nobat 200 mg Film - coated
tablet
Oral use
Cyprus Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/Hctz Fair-med 160 mg/12,5 mg
Film - coated tablet
Oral use
Cyprus Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
164-51 Athens Greece
Donepezil hydrochloride
Donepezil/Generics 5 mg Orodispersible tablet
Oral use
Cyprus Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
164-51 Athens Greece
Donepezil hydrochloride
Donepezil/Generics 10 mg Orodispersible tablet
Oral use
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Cyprus Lambda Therapeutic Limited Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF United Kingdom
Ropinirole hydrochloride
Ropinirole Lambda 0,25 mg Film - coated tablet
Oral use
Cyprus Lambda Therapeutic Limited Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF United Kingdom
Ropinirole hydrochloride
Ropinirole Lambda 0,5 mg Film - coated tablet
Oral use
Cyprus Lambda Therapeutic Limited Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF United Kingdom
Ropinirole hydrochloride
Ropinirole Lambda 1 mg Film - coated tablet
Oral use
Cyprus Lambda Therapeutic Limited Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF United Kingdom
Ropinirole hydrochloride
Ropinirole Lambda 2 mg Film - coated tablet
Oral use
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Cyprus Lambda Therapeutic Limited Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF United Kingdom
Ropinirole hydrochloride
Ropinirole Lambda 5 mg Film - coated tablet
Oral use
Cyprus Wockhardt UK Limited Ash Road North
Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom
Clopidogrel hydrochloride
Clopidogrel/Wockhardt 75 mg Film - coated tablet
Oral use
Czech Republic Abbott Laboratories, s.r.o.
Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park
Czech Republic
Escitalopram oxalate
Purcema 5 mg 5 mg Film - coated
tablet
Oral use
Czech Republic Abbott Laboratories, s.r.o.
Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park
Czech Republic
Escitalopram oxalate
Purcema 10 mg 10 mg Film - coated tablet
Oral use
Czech Republic Abbott Laboratories, s.r.o.
Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park
Czech Republic
Escitalopram oxalate
Purcema 15 mg 15 mg Film - coated tablet
Oral use
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Czech Republic Abbott Laboratories, s.r.o.
Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park
Czech Republic
Escitalopram oxalate
Purcema 20 mg 20 mg Film - coated tablet
Oral use
Czech Republic Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Metformin hydrochloride
Metformin Actavis Retard 500 mg
500 mg Prolonged - release tablet
Oral use
Czech Republic Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Metformin hydrochloride
Metformin Actavis Retard 750 mg
750 mg Prolonged - release tablet
Oral use
Czech Republic Alkaloid - INT d.o.o.
Šlandrova 4
1231 Ljubljana - Črnuče Slovenia
Cefpodoxime Forexo 200 mg potahované tablety
200 mg Film - coated tablet
Oral use
Czech Republic Alvogen IPCo S.ar.l.
Rue Heienhaff 5 L-1736 Senningerberg Luxembourg
Desloratadine Desloratadin Alvogen 5 mg potahované tablety
5 mg Film - coated tablet
Oral use
Czech Republic Apotex Europe B.V.
Darwinweg 20 NL 2333 CR Leiden Netherlands
Trimetazidine dihydrochloride
Apo-trimetazidin 35 mg 35 mg Prolonged - release tablet
Oral use
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Czech Republic Generics (UK) Ltd
Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Esomeprazole magnesium
Esomylan 40 mg 40 mg Gastro - resistant capsule, hard
Oral use
Czech Republic Generics (UK) Ltd
Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Rizatriptan benzoate
Rizatriptan Mylan 5 mg 5 mg Orodispersible tablet
Oral use
Czech Republic Generics (UK) Ltd
Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Rizatriptan benzoate
Rizatriptan Mylan 10 mg 10 mg Orodispersible tablet
Oral use
Czech Republic Generics (UK) Ltd
Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Donepezil hydrochloride
Donepezil Mylan 10 mg 10 mg Orodispersible tablet
Oral use
Czech Republic Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b 14078 Praha 4 Czech Republic
Trimetazidine dihydrochloride
Portora 35 mg tablety s prodlouženým uvolňováním
35 mg Prolonged - release tablet
Oral use
Czech Republic GNR Czech s.r.o.
Slavojova 579/9 128 00 Praha 2 Czech Republic
Desloratadine Geslora 5 mg 5 mg Film - coated
tablet
Oral use
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Czech Republic Labormed-Pharma, SA Theodor Pallady, 44B 032266 Bucharest Romania
Desloratadine Desloratadin Labormed 2,5 mg tablety dispergovatelné v ústech
2,5 mg Orodispersible tablet
Oral use
Czech Republic Labormed-Pharma, SA Theodor Pallady, 44B 032266 Bucharest Romania
Desloratadine Desloratadin Labormed 5 mg tablety dispergovatelné v ústech
5 mg Orodispersible tablet
Oral use
Czech Republic Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Trimetazidine Trimetazidin Mylan 35 mg 35 mg Prolonged - release tablet
Oral use
Czech Republic SVUS Pharma a.s.
Smetanovo nábřeží 1238/20a 500 02 Hradec Králové Czech Republic
Desloratadine Lotera 5 mg potahované tablety
5 mg Film - coated tablet
Oral use
Denmark Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Metformin Metformin "Actavis PTC" 500 mg Prolonged - release tablet
Oral use
Denmark Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Metformin Metformin "Actavis PTC" 750 mg Prolonged - release tablet
Oral use
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Denmark Bluefish Pharmaceuticals AB Torsgatan 11
SE-11123 Stockholm Sweden
Fluconazole Fluconazol "Bluefish" 50 mg Capsule, hard Oral use
Denmark Bluefish Pharmaceuticals AB Torsgatan 11
SE-11123 Stockholm Sweden
Fluconazole Fluconazol "Bluefish" 150 mg Capsule, hard Oral use
Denmark Bluefish Pharmaceuticals AB Torsgatan 11
SE-11123 Stockholm Sweden
Fluconazole Fluconazol "Bluefish" 200 mg Capsule, hard Oral use
Denmark Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/hydrochlorthiazid
"Fair-Med"
160 mg/12,5 mg
Film - coated tablet
Oral use
Denmark Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/hydrochlorthiazid
"Fair-Med"
320 mg/12,5 mg
Film - coated tablet
Oral use
Denmark Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/hydrochlorthiazid
"Fair-Med"
320 mg/25 mg
Film - coated tablet
Oral use
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Denmark Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Eletriptan Eletriptan Mylan 40 mg Film - coated tablet
Oral use
Denmark Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant capsule, hard
Oral use
Denmark Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Esomeprazole Esomeprazol Mylan 40 mg Gastro - resistant capsule, hard
Oral use
Denmark Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Rizatriptan Rizatriptan Mylan 10 mg Orodispersible tablet
Oral use
Denmark Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Germany
Entacapone Entacapon STADA 200 mg Film - coated tablet
Oral use
Estonia Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Alendronic acid ALENDRONIC ACID ACCORD 70mg
70 mg Tablet Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Estonia Sandoz Pharmaceuticals d.d.
Verovskova 57 Ljubljana SI-1000 Slovenia
Trimetazidine ZIDMETIN 35 mg Modified - release tablet
Oral use
Finland Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Metformin Metformin Actavis 500 mg Prolonged - release tablet
Oral use
Finland Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Metformin Metformin Actavis 750 mg Prolonged - release tablet
Oral use
Finland Bluefish Pharmaceuticals AB Torsgatan 11
SE-11123 Stockholm Sweden
Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Oral use
Finland Bluefish Pharmaceuticals AB Torsgatan 11
SE-11123 Stockholm Sweden
Fluconazole Fluconazol Bluefish 150 mg Capsule, hard Oral use
Finland Bluefish Pharmaceuticals AB Torsgatan 11
SE-11123 Stockholm Sweden
Fluconazole Fluconazol Bluefish 200 mg Capsule, hard Oral use
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Finland Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Eletriptan Eletriptan Mylan 40 mg Film - coated tablet
Oral use
Finland Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Repaglinide Repaglinid Mylan 0,5 mg Tablet Oral use
Finland Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Repaglinide Repaglinid Mylan 1 mg Tablet Oral use
Finland Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden
Repaglinide Repaglinid Mylan 2 mg Tablet Oral use
Finland Orion Corporation Orion Pharma PO BOX 65 02101 Espoo Finland
Valsartan VALSARTAN ORION 40 mg Film - coated
tablet
Oral use
Finland Orion Corporation Orion Pharma PO BOX 65 02101 Espoo Finland
Valsartan VALSARTAN ORION 80 mg Film - coated
tablet
Oral use
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Finland Orion Corporation Orion Pharma PO BOX 65 02101 Espoo Finland
Valsartan VALSARTAN ORION 160 mg Film - coated tablet
Oral use
Finland Orion Corporation Orion Pharma PO BOX 65 02101 Espoo Finland
Valsartan VALSARTAN ORION 320 mg Film - coated tablet
Oral use
Finland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Desloratadine Desloratadine Ratiopharm 2,5 mg Orodispersible tablet
Oral use
Finland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Desloratadine Desloratadine Ratiopharm 5 mg Orodispersible tablet
Oral use
France Abbott Products SAS 42 rue Rouget de Lisle 92150 Suresnes France
Escitalopram ESCITALOPRAM ABBOTT 5mg, comprimé pelliculé
5 mg Film - coated tablet
Oral use
France Abbott Products SAS 42 rue Rouget de Lisle 92150 Suresnes France
Escitalopram ESCITALOPRAM ABBOTT 10mg, comprimé pelliculé
10 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Abbott Products SAS 42 rue Rouget de Lisle 92150 Suresnes France
Escitalopram ESCITALOPRAM ABBOTT 15mg, comprimé pelliculé
15 mg Film - coated tablet
Oral use
France Abbott Products SAS 42 rue Rouget de Lisle 92150 Suresnes France
Escitalopram ESCITALOPRAM ABBOTT 20mg, comprimé pelliculé
20 mg Film - coated tablet
Oral use
France ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix 59000 Lille
France
Ropinirole Ropinirole Accord 0,25mg, comprimé pelliculé
0,25 mg Film - coated tablet
Oral use
France ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix 59000 Lille
France
Ropinirole Ropinirole Accord 0,5mg, comprimé pelliculé
0,5 mg Film - coated tablet
Oral use
France ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix 59000 Lille
France
Ropinirole Ropinirole Accord 1mg, comprimé pelliculé
1 mg Film - coated tablet
Oral use
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France ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix 59000 Lille
France
Ropinirole Ropinirole Accord 2mg, comprimé pelliculé
2 mg Film - coated tablet
Oral use
France ACCORD HEALTHCARE France SAS
45 Rue de Fbg de Roubaix 59000 Lille
France
Ropinirole Ropinirole Accord 5mg, comprimé pelliculé
5 mg Film - coated tablet
Oral use
France Brown & Burk UK, Ltd.
5, Marryat Close Hounslow
TW4 5DQ Middlesex United Kingdom
Escitalopram ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable
5 mg Film - coated tablet
Oral use
France Brown & Burk UK, Ltd.
5, Marryat Close Hounslow
TW4 5DQ Middlesex United Kingdom
Escitalopram ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable
10 mg Film - coated tablet
Oral use
France Brown & Burk UK, Ltd.
5, Marryat Close Hounslow
TW4 5DQ Middlesex United Kingdom
Escitalopram ESCITALOPRAM BROWN 15 mg, comprimé pelliculé sécable
15 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Brown & Burk UK, Ltd.
5, Marryat Close Hounslow
TW4 5DQ Middlesex United Kingdom
Escitalopram ESCITALOPRAM BROWN 20 mg, comprimé pelliculé sécable
20 mg Film - coated tablet
Oral use
France Brown & Burk UK, Ltd.
5, Marryat Close Hounslow
TW4 5DQ Middlesex United Kingdom
Ebastine EBASTINE BROWN & BURK 10 mg, comprimé
orodispersible
10 mg Orodispersible tablet
Oral use
France Cristers
22, quai Galliéni 92150 Suresnes France
Desloratadine DESLORATADINE CRISTERS 5 mg
comprimé pelliculé
5 mg Film - coated tablet
Oral use
France Cristers
22, quai Galliéni 92150 Suresnes France
Ibuprofen IBUPROFENE CRISTERS 400 mg
comprimé pelliculé
400 mg Film - coated tablet
Oral use
France Laboratoires Biogaran 15, boulevard Charles de Gaulle
92707 Colombes Cedex France
Ebastine EBASTINE BIOGARAN 10 mg comprimé pelliculé
10 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Laboratoires Biogaran 15, boulevard Charles de Gaulle
92707 Colombes Cedex France
Ebastine EBASTINE BIOGARAN 10 mg comprimé
orodispersible
10 mg Orodispersible tablet
Oral use
France Laboratoires GERDA 24 rue Erlanger 75016 PARIS France
Desloratadine DESLORATADINE ARROW 5 mg
comprimé pelliculé
5 mg Film - coated tablet
Oral use
France Medipha Sante
Les Fjords - Immeuble Oslo 19 avenue de Norvège 91953 Courtaboeuf Cedex France
Tramadol/paraceta mol
TRAMADOL PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé
37,5 mg/325 mg
Film - coated tablet
Oral use
France Medipha Sante
Les Fjords - Immeuble Oslo 19 avenue de Norvège 91953 Courtaboeuf Cedex France
Desloratadine DESLORATADINE GNR 5 mg
comprimé pelliculé
5 mg Film - coated tablet
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Rizatriptan RIZATRIPTAN MYLAN 5mg, orodispersible tablet
5 mg Orodispersible tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Rizatriptan RIZATRIPTAN MYLAN 10 mg, orodispersible tablet
10 mg Orodispersible tablet
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Ebastine EBASTINE MYLAN 10mg, film-coated tablet
10 mg Film - coated tablet
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Ebastine EBASTINE MYLAN 10mg, orodispersible tablet
10 mg Orodispersible tablet
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Trimetazidine TRIMETAZIDINE MYLAN 35 mg Modified Release Tablets
35 mg Modified - release tablet
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Candesartan CANDESARTAN MYLAN 32 mg, comprimé secable
32 mg Tablet Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Donepezil DONEPEZIL MYLAN 5 mg, orodispersible tablet
5 mg Orodispersible tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Donepezil DONEPEZIL MYLAN 10 mg, orodispersible tablet
10 mg Orodispersible tablet
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Esomeprazole ESOMEPRAZOLE MYLAN PHARMA 20mg, DR capsule
20 mg Gastro - resistant capsule, hard
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Esomeprazole ESOMEPRAZOLE MYLAN PHARMA 40mg, DR capsule
40 mg Gastro - resistant capsule, hard
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Desmopressin DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
0,06 mg Orodispersible tablet
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Desmopressin DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
0,12 mg Orodispersible tablet
Oral use
France Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Desmopressin DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
0,24 mg Orodispersible tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton 92800 Puteaux
France
Aciclovir Aciclovir Ranbaxy 800 mg, comprimé
800 mg Tablet Oral use
France Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton 92800 Puteaux
France
Aciclovir Aciclovir Ranbaxy 200 mg, comprimé
200 mg Tablet Oral use
France Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton 92800 Puteaux
France
Aciclovir Aciclovir Almus 200 mg, comprimé
200 mg Tablet Oral use
France Ranbaxy Pharmacie Generiques
11-15 Quai Dion Bouton 92800 Puteaux
France
Alendronic acid Acide Alendronique
Ranbaxy 70 mg, comprimé
70 mg Tablet Oral use
France Sanofi Aventis France 1-13 bd Romain Rolland 75159 Paris Cedex 14 France
Ebastine EBASTINE ZENTIVA 10 mg comprimé pelliculé
10 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Sanofi Aventis France 1-13 bd Romain Rolland 75159 Paris Cedex 14 France
Ebastine EBASTINE ZENTIVA 10 mg comprimé orodispersible
10 mg Orodispersible tablet
Oral use
France Teva Sante
Cœur Défense - 100-110 Esplanade du Général de Gaulle
92931 La Défense Cedex France
Desloratadine DESLORATADINE TEVA SANTE
5 mg
comprimé pelliculé
5 mg Film - coated tablet
Oral use
France Venipharm SAS
4 Bureaux de la Colline 92213 Saint-Cloud France
Ebastine EBOUDA 10 mg comprimé pelliculé
10 mg Film - coated tablet
Oral use
France Venipharm SAS
4 Bureaux de la Colline 92213 Saint-Cloud France
Ebastine EBARREN 10 mg comprimé pelliculé
10 mg Film - coated tablet
Oral use
France Venipharm SAS
4 Bureaux de la Colline 92213 Saint-Cloud France
Ebastine EBONDE 10 mg comprimé pelliculé
10 mg Film - coated tablet
Oral use
France Venipharm SAS
4 Bureaux de la Colline 92213 Saint-Cloud France
Ebastine EBONTAN 10 mg comprimé orodispersible
10 mg Orodispersible tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Venipharm SAS
4 Bureaux de la Colline 92213 Saint-Cloud France
Ebastine EBACHOI 10 mg comprimé orodispersible
10 mg Orodispersible tablet
Oral use
France Venipharm SAS
4 Bureaux de la Colline 92213 Saint-Cloud France
Ibuprofen IBUPROFENE ZYDUS FRANCE 200 mg comprimé pelliculé
200 mg Film - coated tablet
Oral use
France Zydus France
Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Ibuprofen IBUPROFENE ZYDUS FRANCE 400 mg comprimé pelliculé
400 mg Film - coated tablet
Oral use
France Zydus France
Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Tramadol/paraceta mol
TRAMADOL PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé
37,5 mg/325 mg
Film - coated tablet
Oral use
France Zydus France
Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Ibuprofen IBUPROFENE ZF 400 mg comprimé pelliculé
400 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Zydus France
Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Desloratadine DESLORATADINE ZYDUS 5 mg comprimé pelliculé
5 mg Film - coated tablet
Oral use
France Zydus France
Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Escitalopram ESCITALOPRAM ZYDUS 5 mg, comprimé pelliculé
5 mg Film - coated tablet
Oral use
France Zydus France
Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Escitalopram ESCITALOPRAM ZYDUS 10 mg, comprimé pelliculé sécable
10 mg Film - coated tablet
Oral use
France Zydus France
Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Escitalopram ESCITALOPRAM ZYDUS 15 mg, comprimé pelliculé sécable
15 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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France Zydus France
Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Escitalopram ESCITALOPRAM ZYDUS 20 mg, comprimé pelliculé sécable
20 mg Film - coated tablet
Oral use
Germany Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Alendronic acid ALENDRONIC ACID ACCORD 70MG
70 mg Tablet Oral use
Germany betapharm Arzneimittel GmbH Kobelweg 95
D-86156 Augsburg Germany
Levetiracetam Levetiracetam beta 250 mg, Filmtabletten
250 mg Film - coated tablet
Oral use
Germany betapharm Arzneimittel GmbH Kobelweg 95
D-86156 Augsburg Germany
Levetiracetam Levetiracetam beta 500 mg, Filmtabletten
500 mg Film - coated tablet
Oral use
Germany betapharm Arzneimittel GmbH Kobelweg 95
D-86156 Augsburg Germany
Levetiracetam Levetiracetam beta 750 mg, Filmtabletten
750 mg Film - coated tablet
Oral use
Germany betapharm Arzneimittel GmbH Kobelweg 95
D-86156 Augsburg Germany
Levetiracetam Levetiracetam beta 1000 mg, Filmtabeltten
1000 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Irbesartan Irbesartan Tablets 75mg
75 mg Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Irbesartan Irbesartan Tablets 150mg
150 mg Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Irbesartan Irbesartan Tablets 300 mg
300 mg Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Irbesartan/hydroch lorothiazide
Irbesartan HCTZ Fair-Med 150+12,5 mg Filmtabletten
150 mg/12,5 mg
Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Irbesartan/hydroch lorothiazide
Irbesartan HCTZ Fair-Med 300+12,5 mg Filmtabletten
300 mg/12,5 mg
Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Irbesartan/hydroch lorothiazide
Irbesartan HCTZ Fair-Med 300+25 mg Filmtabletten
300 mg/25 mg
Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/HCTZ Fair-Med Healthcare 160 mg/12.5 mg Filmtabletten
160 mg/12,5 mg
Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/HCTZ Fair-Med Healthcare 320 mg/12,5 mg Filmtabletten
320 mg/12,5 mg
Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/HCTZ Fair-Med Healthcare 320 mg/25 mg Filmtabletten
320 mg/25 mg
Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Venlafaxine Venlafaxin Fair-Med 37,5 mg Hartkapseln, retardiert
37,5 mg Prolonged - release capsule, hard
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Venlafaxine Venlafaxin Fair-Med 75 mg Hartkapseln, retardiert
75 mg Prolonged - release capsule, hard
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Venlafaxine Venlafaxin Fair-Med 150 mg Hartkapseln, retardiert
150 mg Prolonged - release capsule, hard
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Ciprofloxacin Ciprofloxacin Fair-Med Healthcare 500 mg Filmtabletten
500 mg Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Ciprofloxacin Ciprofloxacin Fair-Med Healthcare 750 mg Filmtabletten
750 mg Film - coated tablet
Oral use
Germany Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Ciprofloxacin Ciprofloxacin Fair-Med Healthcare 250 mg Filmtabletten
250 mg Film - coated tablet
Oral use
Germany Heumann Pharma GmbH &
Co. Generica KG Südwestpark 50 90449 Nürnberg Germany
Irbesartan Irbesartan Heumann 75 mg Filmtabletten
75 mg Film - coated tablet
Oral use
Germany Heumann Pharma GmbH &
Co. Generica KG Südwestpark 50 90449 Nürnberg Germany
Irbesartan Irbesartan Heumann 150 mg Filmtabletten
150 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Germany Heumann Pharma GmbH &
Co. Generica KG Südwestpark 50 90449 Nürnberg Germany
Irbesartan Irbesartan Heumann 300 mg Filmtabletten
300 mg Film - coated tablet
Oral use
Germany Heumann Pharma GmbH &
Co. Generica KG Südwestpark 50 90449 Nürnberg Germany
Irbesartan/hydroch lorothiazide
Irbesartan/Hydrochlorothia zid Heumann 150 mg/12.5 mg Filmtabletten
150 mg/12,5 mg
Film - coated tablet
Oral use
Germany Heumann Pharma GmbH &
Co. Generica KG Südwestpark 50 90449 Nürnberg Germany
Irbesartan/hydroch lorothiazide
Irbesartan/Hydrochlorothia zid Heumann 300 mg/12.5 mg Filmtabletten
300 mg/12,5 mg
Film - coated tablet
Oral use
Germany Heumann Pharma GmbH &
Co. Generica KG Südwestpark 50 90449 Nürnberg Germany
Irbesartan/hydroch lorothiazide
Irbesartan/Hydrochlorothia zid Heumann 300 mg/25 mg Filmtabletten
300 mg/25 mg
Film - coated tablet
Oral use
Germany Hormosan Pharma GmbH Wilhelmshoeher Str. 106 D-60389 Frankfurt 06 Hessen
Germany
Cefpodoxime proxetil
Cefpodoxim- Hormosan 200mg Filmtabletten
200 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Germany Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF
United Kingdom
Trimetazidine hydrochloride
Lupamadazine 35 mg Retardtabletten
35 mg Controlled - release tablet
Oral use
Germany Micro Labs GmbH Lyoner Str. 14
D-60528 Frankfurt/Main Germany
Escitalopram Escitalopram-Micro Labs 5 mg Filmtabletten
5 mg Film - coated tablet
Oral use
Germany Micro Labs GmbH Lyoner Str. 14
D-60528 Frankfurt/Main Germany
Escitalopram Escitalopram-Micro Labs 10 mg Filmtabletten
10 mg Film - coated tablet
Oral use
Germany Micro Labs GmbH Lyoner Str. 14
D-60528 Frankfurt/Main Germany
Escitalopram Escitalopram-Micro Labs 15 mg Filmtabletten
15 mg Film - coated tablet
Oral use
Germany Micro Labs GmbH Lyoner Str. 14
D-60528 Frankfurt/Main Germany
Escitalopram Escitalopram-Micro Labs 20 mg Filmtabletten
20 mg Film - coated tablet
Oral use
Germany Mylan dura GmBh Wittichstrasse 6 64295 Darmstadt Germany
Repaglinide Repaglinid Mylan 0,5 mg Tabletten
0,5 mg Tablet Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Germany Mylan dura GmBh Wittichstrasse 6 64295 Darmstadt Germany
Repaglinide Repaglinid Mylan 1 mg Tabletten
1 mg Tablet Oral use
Germany Mylan dura GmBh Wittichstrasse 6 64295 Darmstadt Germany
Repaglinide Repaglinid Mylan 2 mg Tabletten
2 mg Tablet Oral use
Germany Mylan dura GmBh Wittichstrasse 6 64295 Darmstadt Germany
Rizatriptan Rizatriptan Mylan dura 5 mg Schmelztabletten
5 mg Orodispersible tablet
Oral use
Germany Mylan dura GmBh Wittichstrasse 6 64295 Darmstadt Germany
Rizatriptan Rizatriptan Mylan dura 10 mg Schmelztabletten
10 mg Orodispersible tablet
Oral use
Germany Panacea Biotec Germany GmbH
Landshuter Allee 8-10 D-80637 München Germany
Tacrolimus Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Oral use
Germany Panacea Biotec Germany GmbH
Landshuter Allee 8-10 D-80637 München Germany
Tacrolimus Tacpan 1 mg Hartkapseln 1 mg Capsule, hard Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Germany Panacea Biotec Germany GmbH
Landshuter Allee 8-10 D-80637 München Germany
Tacrolimus Tacpan 5 mg Hartkapseln 5 mg Capsule, hard Oral use
Germany Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Germany
Entacapone Entacapon STADA 200 mg Filmtabletten
200 mg Film - coated tablet
Oral use
Germany Unichem Laboratories Ltd.
Studio 8B Ard Gaoithe Commercial Centre, Business Park
Cashel Road Clonmel, Co Tipperary
Ireland
Irbesartan Irbesartan Unichem 150 mg Filmtabletten
150 mg Film - coated tablet
Oral use
Germany Unichem Laboratories Ltd.
Studio 8B Ard Gaoithe Commercial Centre, Business Park
Cashel Road Clonmel, Co Tipperary
Ireland
Irbesartan Irbesartan Unichem 300 mg Filmtabletten
300 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Germany Welding GmbH & Co. KG Esplanade 39
D-20354 Hamburg Germany
Irbesartan/hydroch lorothiazide
Irbesartan +
Hidroclorotiazida Welding
300 mg/12,5 mg
Film - coated tablet
Oral use
Germany Welding GmbH & Co. KG Esplanade 39
D-20354 Hamburg Germany
Irbesartan/hydroch lorothiazide
Irbesartan +
Hidroclorotiazida Welding
150 mg/12,5 mg
Film - coated tablet
Oral use
Germany Welding GmbH & Co. KG Esplanade 39
D-20354 Hamburg Germany
Irbesartan/hydroch lorothiazide
Irbesartan +
Hidroclorotiazida Welding
300 mg/25 mg
Film - coated tablet
Oral use
Germany Welding GmbH & Co. KG Esplanade 39
D-20354 Hamburg Germany
Irbesartan Irbesartan Welding 75 mg Film - coated tablet
Oral use
Germany Welding GmbH & Co. KG Esplanade 39
D-20354 Hamburg Germany
Irbesartan Irbesartan Welding 150 mg Film - coated tablet
Oral use
Germany Welding GmbH & Co. KG Esplanade 39
D-20354 Hamburg Germany
Irbesartan Irbesartan Welding 300 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Greece Abbott Laboratories Hellas ΑΒΕΕ
Agiou Dimitriou 63 Alimos 17456 Greece
Escitalopram oxalate
Savandra 5 mg Film - coated
tablet
Oral use
Greece Abbott Laboratories Hellas ΑΒΕΕ
Agiou Dimitriou 63 Alimos 17456 Greece
Escitalopram oxalate
Savandra 10 mg Film - coated
tablet
Oral use
Greece Abbott Laboratories Hellas ΑΒΕΕ
Agiou Dimitriou 63 Alimos 17456 Greece
Escitalopram oxalate
Savandra 15 mg Film - coated
tablet
Oral use
Greece Abbott Laboratories Hellas ΑΒΕΕ
Agiou Dimitriou 63 Alimos 17456 Greece
Escitalopram oxalate
Savandra 20 mg Film - coated
tablet
Oral use
Greece Genepharm S.A.
18 Km Marathon Avenue, 15351 Pallini
Greece
Desloratadine Desloratadine/Genepharm 5 mg δισκία επικαλυμμένα με υμένιο,
5 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Greece Genepharm S.A.
18 Km Marathon Avenue, 15351 Pallini
Greece
Desloratadine Desloratadine/Genepharm 2,5 mg δισκία
διασπειρόμενα στο στόμα
2,5 mg Orodispersible tablet
Oral use
Greece Genepharm S.A.
18 Km Marathon Avenue, 15351 Pallini
Greece
Desloratadine Desloratadine/Genepharm 5 mg δισκία διασπειρόμενα στο στόμα
5 mg Orodispersible tablet
Oral use
Greece Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
164-51 Athens Greece
Donepezil hydrochloride
Donepezil/ Generics 5 mg Orodispersible tablet
Oral use
Greece Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
164-51 Athens Greece
Donepezil hydrochloride
Donepezil/ Generics 10 mg Orodispersible tablet
Oral use
Greece Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
164-51 Athens Greece
Esomeprazole magnesium
Esomeprazole/ Generics 40 mg Prolonged - release capsule
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 43/131
Greece Sieger Pharma A.E.
Marathonos Avenue 106 Pikermi 19009
Greece
Desloratadine Desloratadine/Sieger 5 mg Film - coated tablet
Oral use
Greece Sieger Pharma A.E.
Marathonos Avenue 106 Pikermi 19009
Greece
Desloratadine Desloratadine/Sieger 2,5 mg Orodispersible tablet
Oral use
Greece Sieger Pharma A.E.
Marathonos Avenue 106 Pikermi 19009
Greece
Desloratadine Desloratadine/Sieger 5 mg Orodispersible tablet
Oral use
Hungary Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Metformin hydrochloride
Gluforlyn XR 500 mg retard tabletta
500 mg Prolonged - release tablet
Oral use
Hungary Alvogen IPCo S.ar.l.
Rue Heienhaff 5 L-1736 Senningerberg Luxembourg
Desloratadine Alvotadin 5 mg filmtabletta 5 mg Film - coated tablet
Oral use
Hungary Alvogen IPCo S.ar.l.
Rue Heienhaff 5 L-1736 Senningerberg Luxembourg
Desloratadine Alvotadin 2.5 mg szájban diszpergálódó tabletta
2,5 mg Orodispersible tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Hungary Alvogen IPCo S.ar.l.
Rue Heienhaff 5 L-1736 Senningerberg Luxembourg
Desloratadine Alvotadin 5 mg szájban diszpergálódó tabletta
5 mg Orodispersible tablet
Oral use
Hungary Generics (UK) Ltd
Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Esomeprazole magnesium
Esomeprazol Mylan 20 mg gyomornedv-ellenálló kemény kapszula
20 mg Gastro - resistant capsule, hard
Oral use
Hungary Generics (UK) Ltd
Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Esomeprazole magnesium
Esomeprazol Mylan 40 mg gyomornedv-ellenálló kemény kapszula
40 mg Gastro - resistant capsule, hard
Oral use
Hungary Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b 14078 Praha 4 Czech Republic
Trimetazidine dihydrochloride
Apstar 35 mg retard tabletta
35 mg Prolonged - release tablet
Oral use
Hungary Goodwill Pharma Kft.
H-6724 Szeged Cserzy Mihály u. 32.
Hungary
Desloratadine Inaller 5 mg filmtabletta 5 mg Film - coated tablet
Oral use
Hungary Mylan SAS
117 allée des Parcs 69792 Saint-Priest Cedex France
Trimetazidine Trimetazidine Mylan 35 mg retard tabletta
35 mg Prolonged - release tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
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Hungary Sandoz Hungária Kft.
H-1114 Budapest Bartók Béla út 43-47.
Hungary
Trimetazidine dihydrochloride
Trimetazidine Sandoz 35 mg retard tabletta
35 mg Prolonged - release tablet
Oral use
Hungary Teva Gyógyszergyár Zrt.
H-4042 Debrecen Pallagi út 13.
Hungary
Desloratadine Desloratadin Teva 2.5 mg szájban diszpergálódó tabletta
2,5 mg Orodispersible tablet
Oral use
Hungary Teva Gyógyszergyár Zrt.
H-4042 Debrecen Pallagi út 13.
Hungary
Desloratadine Desloratadin Teva 5 mg szájban diszpergálódó tabletta
5 mg Orodispersible tablet
Oral use
Iceland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Desloratadine Desloratadine ratiopharm 5 mg Orodispersible tablet
Oral use
Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole hydrochloride
Ropinirole 0.25 mg Film- coated Tablets
0,25 mg Film - coated tablet
Oral use
Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole hydrochloride
Ropinirole 0.5 mg Film- coated Tablets
0,5 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 46/131
Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole hydrochloride
Ropinirole 1 mg Film- coated Tablets
1 mg Film - coated tablet
Oral use
Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole hydrochloride
Ropinirole 2 mg Film- coated Tablets
2 mg Film - coated tablet
Oral use
Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Ropinirole hydrochloride
Ropinirole 5 mg Film- coated Tablets
5 mg Film - coated tablet
Oral use
Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Alendronic acid Alendronic Acid Once Weekly 70 mg Tablets
70 mg Tablet Oral use
Ireland Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/Hydrochlorothiaz ide Fair-Med 160 mg/12.5 mg film-coated tablets.
160 mg/12,5 mg
Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 47/131
Ireland Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/12.5 mg film-coated tablets
320 mg/12,5 mg
Film - coated tablet
Oral use
Ireland Fair-Med Healthcare GmbH Planckstrasse 13
DE-22765 Hamburg Germany
Valsartan/hydrochl orothiazide
Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/25 mg film-coated tablets
320 mg/25 mg
Film - coated tablet
Oral use
Ireland Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Northamptonshire NN8 6GT United Kingdom
Fexofenadine hydrochloride
Fexofenadine 120 mg film- coated tablets
120 mg Film - coated tablet
Oral use
Ireland Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Northamptonshire NN8 6GT United Kingdom
Fexofenadine hydrochloride
Fexofenadine 180 mg film- coated tablets
180 mg Film - coated tablet
Oral use
Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Donepezil Aripil Orotab 5mg Orodispersible Tablet
5 mg Orodispersible tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 48/131
Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Donepezil Aripil Orotab 10mg Orodispersible Tablet
10 mg Orodispersible tablet
Oral use
Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Esomeprazole Esomeprazole Mylan 20 mg Gastro-resistant Capsules, hard
20 mg Gastro - resistant capsule
Oral use
Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Esomeprazole Esomeprazole Mylan 40 mg Gastro-resistant Capsules, hard
40 mg Gastro - resistant capsule
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 49/131
Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Candesartan Candesartan Mylan 4mg Tablets
4 mg Tablet Oral use
Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Candesartan Candesartan Mylan 8 mg Tablets
8 mg Tablet Oral use
Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Candesartan Candesartan Mylan 16 mg Tablets
16 mg Tablet Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 50/131
Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Candesartan Candesartan Mylan 32 mg Tablets
32 mg Tablet Oral use
Ireland Morningside Healthcare Limited
115 Narborough Road Leicester, LE3 0PA United Kingdom
Phenoxymethyl penicillin
Phenoxymethylpenicillin 250mg Film-coated Tablets
250 mg Film - coated tablet
Oral use
Ireland Niche Generics Limited 1 The Cam Centre Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
Amlodipine besilate Amlodipine Niche 5mg tablets
5 mg Tablet Oral use
Ireland Niche Generics Limited 1 The Cam Centre Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
Amlodipine besilate Amlodipine Niche 10mg Tablets
10 mg Tablet Oral use
Ireland Niche Generics Limited 1 The Cam Centre Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
Irbesartan Irbesartan Niche 150mg film coated tablets
150 mg Film - coated tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 51/131
Ireland Niche Generics Limited 1 The Cam Centre Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
Irbesartan Irbesartan Niche 300mg film coated tablets
300 mg Film - coated tablet
Oral use
Ireland Wockhardt UK Limited Ash Road North
Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom
Clopidogrel hydrochloride
Clopidogrel 75mg film- coated tablets
75 mg Film - coated tablet
Oral use
Italy Accord Healthcare Italia S.r.l.
Largo Esterle, 4 20052 Monza Italy
Metoclopramide METOCLOPRAMIDE ACCORD
10 mg Tablet Oral use
Italy Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Alendronic acid ALENDRONATO AHCL 10 mg Tablet Oral use
Italy Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
United Kingdom
Alendronic acid ALENDRONATO AHCL 70 mg Tablet Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 52/131
Italy Doc Generici SRL Via Turati, 40 20121 Milano Italy
Desloratadine DESLORATADINA DOC GENERICI
5 mg Film - coated tablet
Oral use
Italy Doc Generici SRL Via Turati, 40 20121 Milano Italy
Desloratadine DESLORATADINA DOC GENERICI
2,5 mg Orodispersible tablet
Oral use
Italy Doc Generici SRL Via Turati, 40 20121 Milano Italy
Desloratadine DESLORATADINA DOC GENERICI
5 mg Orodispersible tablet
Oral use
Italy Farmaceutici Caber S.P.A.
Viale Citta' D'Europa, 681 00144 Rome
Italy
Valsartan VALSOTEN 40 mg Film - coated
tablet
Oral use
Italy Farmaceutici Caber S.P.A.
Viale Citta' D'Europa, 681 00144 Rome
Italy
Valsartan VALSOTEN 80 mg Film - coated
tablet
Oral use
Italy Farmaceutici Caber S.P.A.
Viale Citta' D'Europa, 681 00144 Rome
Italy
Valsartan VALSOTEN 160 mg Film - coated
tablet
Oral use
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 53/131
Italy Farmaceutici Caber S.P.A.
Viale Citta' D'Europa, 681 00144 Rome
Italy
Valsartan VALSOTEN 320 mg Film - coated
tablet
Oral use
Italy Mylan S.P.A.
Via Vittor Pisani, 20 20124 Milan
Italy
Esomeprazole magnesium
ESOMEPRAZOLO MYLAN 20 mg Gastro - resistant capsule, hard
Oral use
Italy Mylan S.P.A.
Via Vittor Pisani, 20 20124 Milan
Italy
Esomeprazole magnesium
ESOMEPRAZOLO MYLAN 40 mg Gastro - resistant capsule, hard
Oral use
Italy Mylan S.P.A.
Via Vittor Pisani, 20 20124 Milan
Italy
Rizatriptan benzoate
RIAZATRIPTAN MYLAN GENERICS
5 mg Orodispersible tablet
Oral use
Italy Mylan S.P.A.
Via Vittor Pisani, 20 20124 Milan
Italy
Rizatriptan benzoate
RIAZATRIPTAN MYLAN GENERICS
10 mg Orodispersible tablet
Oral use
Italy Mylan S.P.A.
Via Vittor Pisani, 20 20124 Milan
Italy
Donepezil hydrochloride
DONEPEZIL MYLAN GENERICS ITALIA
5 mg Orodispersible tablet
Oral use
